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Optimizing Cardiovascular Health and Physical Function in Hemodialysis Patients Through Volume Control and Exercise

NCT02627066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-08-02

No results posted yet for this study

Summary

This is a 12 month randomized clinical trial in which patients with renal failure undergoing maintenance hemodialysis (MHD) therapy will be placed on a volume reduction protocol that includes a novel low sodium dietary education program mediated by a lifestyle interventionist with significant collaboration from the existing clinic staff. Participating patients will be randomized to receive: 1) the volume control protocol alone (VC), or 2) the volume control protocol + physical activity and exercise counseling (VCE) from the lifestyle interventionist (LI). A research dietitian (RD), working in collaboration with the existing clinic RD, will develop a program to immerse clinics in a culture of sodium restriction. The research RD will train the LI and other clinic staff (nurses, technicians, etc) to help disseminate this program, modeled after the clinic-wide dissemination approach used in Izmir, Turkey (Dr. Ercan Ok). In addition, the LI will provide exercise and physical activity counseling to the participants randomized to the exercise group, utilizing a SCT-based approach. The Investigators hypothesize that mean arterial pressure will be reduced, and physical function increased, in all patients at 12 months, but the magnitude of these improvements will be greater in the VCE group.

Conditions

  • Renal Failure

Interventions

BEHAVIORAL

Volume Control

Persistent reduction in post-dialysis weight and dietary sodium restriction

BEHAVIORAL

Volume Control + Exercise

Volume reduction intervention and comprehensive exercise counseling

Sponsors & Collaborators

  • University of Illinois at Urbana-Champaign

    lead OTHER

Principal Investigators

  • Kenneth R Wilund, PhD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-11-30
Completion
2018-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02627066 on ClinicalTrials.gov